True-Lock 9471S

GUDID 05708932987967

Plug

Coloplast A/S

Inflatable penile prosthesis
Primary Device ID05708932987967
NIH Device Record Keye723538d-74c7-41b1-a20c-5a84c00c2f39
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue-Lock
Version Model Number9471S
Catalog Number9471S
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8002583476
Emailurology@coloplast.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932987967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FHWDevice, Impotence, Mechanical/Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-07-21

Devices Manufactured by Coloplast A/S

05701780292795 - SenSura Mio2024-03-18
05701780292801 - SenSura Mio2024-03-18
05701780295123 - SenSura Mio Convex2024-03-18
05701780295130 - SenSura Mio Convex2024-03-18
05701780295147 - SenSura Mio Convex2024-03-18
05701780295154 - SenSura Mio Convex2024-03-18
05701780295161 - SenSura Mio Convex2024-03-18
05701780295178 - SenSura Mio Convex2024-03-18

Trademark Results [True-Lock]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUE-LOCK
TRUE-LOCK
77595270 4031967 Dead/Cancelled
Physio-Control, Inc.
2008-10-17
TRUE-LOCK
TRUE-LOCK
74034121 1622318 Live/Registered
Mentor Corporation
1990-03-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.